NCT01887015

Brief Summary

To evaluate whether early application of nasal high flow oxygen therapy after extubation can reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio \<300) after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

June 24, 2013

Last Update Submit

March 26, 2015

Conditions

Postoperative Hypoxemia

Keywords

Postoperative pulmonary complicationsOxygen therapyNasal high flow oxygen therapyNasal high flow cannula

Outcome Measures

Primary Outcomes (1)

  • percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300)

    1 hour after tracheal extubation (day 1)

Secondary Outcomes (5)

  • Postoperative gas exchange (PaO2, PaCO2)

    1H after extubation and after surgery (at day 1)

  • Need for supplemental oxygen therapy beyond postoperative day 1 (defined as arterial oxygen saturation by pulse oximetry (SpO2) <93% in room air)

    at day 1

  • Need for endotracheal intubation or non-invasive ventilation for postoperative acute respiratory failure (ARF)

    within the first 7 days after surgery

  • Postoperative pulmonary complications (PPCs)

    within the first 7 days after surgery

  • Respiratory discomfort using a numerical rating scale (NRS) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort).

    within the first 7 days after surgery

Study Arms (2)

Standard oxygen therapy

EXPERIMENTAL

Our hypothesis is that, compared with standard oxygen therapy, early application of nasal high flow oxygen therapy can reduce the need for postoperative NPPV for postoperative hypoxemia (defined as PaO2/FiO2 ratio \<300).

Device: Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand)

nasal high flow oxygen therapy

OTHER

Our hypothesis is that, compared with standard oxygen therapy, early application of nasal high flow oxygen therapy can reduce the need for postoperative NPPV for postoperative hypoxemia (defined as PaO2/FiO2 ratio \<300).

Device: Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand)

Interventions

Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand)DEVICE
Also known as: Nasal high flow oxygen therapy versus standard oxygen therapy
Standard oxygen therapynasal high flow oxygen therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned or unplanned surgical procedures
  • Abdominal or abdominal and thoracic surgery
  • Expected duration ≥2 hours
  • ARISCAT score ≥26 points

You may not qualify if:

  • Age \<18 years
  • Body mass index \>35 kg/m2
  • Sleep apnea syndrome
  • Patient refusal
  • Pregnancy and/or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

  • Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.

    PMID: 27771739DERIVED

  • Futier E, Paugam-Burtz C, Constantin JM, Pereira B, Jaber S. The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial. Trials. 2013 Oct 18;14:341. doi: 10.1186/1745-6215-14-341.

    PMID: 24138710DERIVED

Study Officials

  • Emmanuel FUTIER, MD, Ph D

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 26, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

FR(1)